This invention relates to cervical braces for immobilizing a patient""s head, neck, and torso to avoid cervical extension, flexion, or rotation, thereby avoiding damage to the spinal cord. The invention comprises a halo mask and a skin adhesion system in combination with a fixed frame and vest apparatus which substantially immobilize the patient""s head, neck, and torso, while avoiding use of invasive immobilization techniques.
Annually, approximately 10,000 people become paraplegic or quadriplegic because of spinal cord injuries, often as a result of damage to the surrounding vertebral column from fracture, dislocation, or both. Of the nearly ten million people in the U.S. who sustain head injuries annually, many also have an associated instability of the spinal column. With preexisting conditions such as spondylosis, a congenitally narrowed spinal canal, or instability of apophyseal joints of adjacent vertebrae caused by diseases such as rheumatoid arthritis, a patient may suffer severe spinal cord damage after sustaining only minor injuries.
Because hyperextension or flexion is the main cause of injury to the cervical cord, the care of patients who have undergone neck or head injuries, or who are particularly susceptible to spinal cord damage, requires immobilizing areas of the patient""s body which impact the cervical region. Such immobilization prevents initial or continued spinal cord damage. Thus, during the healing process, a patient""s head, neck, and torso should be properly positioned relative to each other and then immobilized to avoid cervical extension, flexion, or rotation which could result in continued or initial damage to the spinal cord.
Conventionally, a patient""s head, neck, and torso are positioned in a predetermined relative orientation and then immobilized by use of a cervical brace. As shown in U.S. Pat. No. 4,620,530 to Lanier et al. and U.S. Pat. No. 4,541,421 to Iversen et al., for example, a conventional cervical brace includes a metal or non-metal ring encircling the parietal and frontal bone of a patient""s skull. The ring, often referred to as a xe2x80x9chalo,xe2x80x9d includes spaced apart skull pins which connect to the parietal bone, temporal bone, sphenoid bone, or frontal bone, or a combination of them, at various locations around the halo. The skull pins may physically penetrate the bone structure of the patient""s skull, or alternatively, they may be pointed screws contacting the patient""s skin surface.
U.S. Pat. No. 3,957,040 to Calabrese discloses a halo type cervical brace in which the halo portion covering the posterior part, of the patient""s head is curved downward to embrace the occipital bone, as opposed to the parietal bone.
The conventional halo-type cervical brace includes a vest and frame structure affixed to the patient""s upper torso. The halo is supported by the frame structure. By properly positioning the vest, halo, and skull pins relative to each other, the patient""s torso, neck, and head are immobilized in a position which avoids placing stress on the spinal cord at a level which would initiate or exacerbate injury. If the patient attempts to move in a manner opposed by the fixed orientation of the halo and vest, the patient is restrained and experiences pain due to the adverse pressure applied by the skull pins directly to the patient""s head. Adverse cervical extension, flexion, and/or rotation are thereby avoided.
Use of penetrating skull pins to achieve full head, neck, and torso immobilization in conventional cervical halo braces causes unnecessary discomfort for the patient and exposes the patient to possible infections at the point of pin contact. In contrast, an objective of this invention is to achieve substantially full immobilization of the patient""s head, neck, and torso without use of such invasive immobilization devices.
Additionally, invasiveness of such conventional cervical braces requires the halo-vest apparatus to be fitted, maintained, and adjusted by highly skilled medical personnel. Another objective of this invention is to provide a cervical brace which can maintain a useful level of immobilization of a patient""s head, neck, and torso, without requiring the same degree of medical assistance required of invasive techniques.
A further objective of this invention is to provide a non-invasive immobilization of a patient""s head, neck, and torso region in a predetermined orientation without incurring any significant slippage so that substantially full immobilization of the patient""s neck, head and torso can be achieved at a level that avoids adverse extension, flexion or rotation of the cervical region.
The present invention provides a non-invasive halo-type cervical brace which represents a marked improvement over existing methods and devices for achieving substantially full immobilization of a patient""s neck, head, and torso to avoid adverse extension, flexion, or rotation of a patient""s cervical region.
One embodiment of the invention comprises a non-invasive halo-type cervical brace which includes a reinforced anterior vest which overlies the chest region of the patient and supports an upright rigid frame structure which holds an immobilizing halo mask around the head of the patient. The rigid frame structure includes a U-shaped halo frame which extends under the chin and along the sides of the patient""s head. The rigid frame structure also includes one or more vertical frame members affixed to the bottom of the halo frame and to the front of the vest by adjustable clamps which position the halo frame around the patient""s head in a desired orientation. The halo mask includes a flexible generally U-shaped trapeze type sling carried within the U-shaped halo frame. The sling extends under the chin and around the sides of the patient""s head generally in alignment with the U-shaped halo frame. The free ends of the sling comprise flexible straps which extend through respective slots on the halo frame and then through respective clamp buckles adjacent the halo frame. The free ends of the sling are pulled through the slots and used to adjust the length of the sling for making a snug fit under the patient""s chin and around the sides of the patient""s head, with the pressure being held tight by fastening the clamp buckles at the sides of the halo frame.
The U-shaped halo frame also carries a two part halo-type support which includes (1) a generally U-shaped semi-rigid forehead band which extends around the forehead and along the sides of the patient""s head, and (2) a padded occiputal support attached to the halo frame by flexible straps adjustable in length for securing the occipital support behind the patient""s head. The U-shaped forehead band is adjustable in length and preferably comprises a pair of opposed curved bars affixed at their ends to the halo frame with their free ends overlying one another adjacent the forehead of the patient. The forehead bars are releasably secured to each other by cooperating friction fasteners for adjusting the length of the U-shaped forehead band and holding it in a fixed position along the forehead and around the sides of the patient""s head. The occipital support is adjusted tightly against the back of the patient""s head by its cooperating adjustable straps to apply pressure in combination with the forehead band in a manner similar to a halo encircling the patient""s head.
Elongated skin adhesion layers are affixed to the inside of the U-shaped forehead band, for applying pressure to the forehead, and to the inside of the sling which extends under and applies pressure to the patient""s chin. The skin adhesion layers comprise a material which provides a level of non-skid frictional contact with the skin sufficient to prevent slippage between the patient""s skin and the tightly adjusted halo and chin support. Preferably, the skin adhesion layer for the inside of the forehead band is carried on a separate flexible strap having a friction fastener surface material cooperating with friction fasteners on the inside of the forehead band for releasably positioning the skin adhesion layer to the inside of the forehead band. In a preferred form of the invention, the skin adhesion layer comprises a reinforced silicone gel material capable of frictionally adhering to the patient""s skin for long periods of time without detrimental effects to the patient""s skin or comfort during use.
By employing the strategically positioned skin adhesion layers in combination with the halo mask, the present invention substantially immobilizes the patient""s head, neck, and torso, thereby preventing the patient from adversely extending, flexing, or rotating the cervical region. Because the present invention provides substantially full immobilization of the patient""s head, neck, and torso without use of invasive immobilization techniques, employing this novel cervical brace does not require the same use of highly skilled medical personnel as a conventional halo type brace with skull penetration pins. In addition, it does not expose the patient to the unnecessary discomfort of skull pin penetration into the patient""s body. By eliminating the use of skull pins, the risk of infection at the point of pin penetration also is eliminated.
Another embodiment of the invention comprises an orthosis for immobilizing a region of a patient""s body utilizing the anti-slip skin adhesion aspect of the present invention. In this embodiment of the invention, the orthosis comprises a rigid outer frame and a flexible orthotic support member secured to the outer frame for contacting a region of the body to be immobilized. The orthotic support member includes an adjustable fastening system for drawing the orthotic support member into pressure contact with the region of the body to be immobilized. A skin adhesion layer secured to the orthotic support member contacts the skin of the patient in the area immobilized by the orthosis. The skin adhesion layer comprises a non-skid surface for enhancing frictional contact with the skin to avoid slippage between the orthotic support member and the skin when the support member is held in immobilizing pressure contact with the bodily region. The invention may be used, for example, in a hip brace, an arm brace, a leg or knee brace, or a cervical-thoracic orthosis.
These and other aspects of the invention will be more fully understood by referring to the following detailed description and the accompanying drawings.